[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54454-54455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21367]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0341]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Safety; Federal-
State Food Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 1, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0760. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Safety; Federal-State Food Regulatory Program Standards

OMB Control Number 0910-0760--Revision

    This information collection supports implementation of FDA's 
Federal-State Regulatory Program Standards, part of our National 
Integrated Food Safety System (IFSS) Programs and Initiatives. For more 
information we invite you to visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. In the 
United States, Federal and State governments work cooperatively to 
ensure the safety of food intended for both human and animal 
consumption. Part of this effort includes developing and maintaining 
uniform review criteria by which to assess food safety. FDA has 
established and maintains a number of program standards aimed at 
improving the safety evaluation for certain food products including 
manufactured foods and animal feed. Similarly, we are establishing 
regulatory program standards for eggs and have developed the ``Eggs 
Regulatory Program Standards'' (ERPS). The ERPS is intended for use by 
State and local regulatory officials and identifies 10 elements we 
believe are essential to the effective regulatory assessment of egg 
safety. States are encouraged to build systems that are sustainable and 
implement plans corresponding to the IFSS.
    In the course of their normal duties, State, local, Territorial, 
and Tribal governments collect information pertaining to compliance 
with the respective State, local, Territorial, and Tribal food safety 
requirements within their jurisdictions. Although content and format of 
the information collected may vary, these activities are a usual and 
customary part of routine regulatory oversight. Respondents to the 
information collection are State, local, Territorial, and Tribal 
regulatory agencies.
    The ERPS offers forms, worksheets, and templates to help 
respondents assess and meet the program elements identified and 
discussed. Respondents are not required to use the sample collection 
instruments included in the ERPS, however all data elements should be 
submitted to FDA and supporting documentation retained. The ERPS is

[[Page 54455]]

not intended to address any performance appraisal processes that any 
State, local, Territorial, or Tribal agency may use to evaluate its 
employees' performance. Funding opportunities are available to 
respondents who choose to implement the ERPS; however, these 
opportunities are limited and contingent upon the availability of 
funds, and are available to those respondents who currently have an egg 
inspection contract with FDA and thus are subject to auditing. A copy 
of the ERPS has been posted to FDA-2021-N-0341 and is available at 
https://www.regulations.gov.
    In the Federal Register of May 14, 2021 (86 FR 26528), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                   Type of respondents; activity                        Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/or Tribal Governments; submission of              10               10              100               50            5,000
 data elements to FDA consistent with ERPS.........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our experience with similar information collection, we 
estimate an initial 10 respondents will participate in the ERPS, and 
assume an average of 50 burden hours per response is necessary for the 
attendant recordkeeping and submission of data elements to FDA. We 
expect participation in the ERPS to increase. Finally, upon submission 
of the Information Collection Request, we are correcting an inadvertent 
calculation error in the total burden hours as displayed on page 26530, 
in Table 1, in our 60-day notice in the Federal Register of May 14, 
2021 (86 FR 26528).

    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21367 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P